Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06078891
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-10-12
First Post:
2023-08-06
Brief Title:
Does BCG Vaccination Reduce Biomarkers of Alzheimers Disease
Sponsor:
Tamir Ben-Hur
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Does BCG Vaccination Reduce Biomarkers of Alzheimers Disease
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BCG-AD
Brief Summary:
The goal of this clinical trial is to test whether vaccination with the BCG vaccine may improve the blood level of a biomarker of Alzheimers disease AD in participants who are cognitively- and functionally- intact elderly 70-80 years old participants who display pathologically high levels of the blood biomarker
The main questions it aims to answer are
Does BCG vaccination lower the plasma level of phosphorylated Tau protein p-tau181
Do vaccinated participants remains stable cognitively
Participants will be asked to
Undergo cognitive and behavioral evaluation
Receive 3 BCG vaccinations over the course of 1 year
Perform blood tests on several occasions All participants will be treated and followed
The main questions it aims to answer are
Does BCG vaccination lower the plasma level of phosphorylated Tau protein p-tau181
Do vaccinated participants remains stable cognitively
Participants will be asked to
Undergo cognitive and behavioral evaluation
Receive 3 BCG vaccinations over the course of 1 year
Perform blood tests on several occasions All participants will be treated and followed
Detailed Description:
Brain accumulation of insoluble Beta-Amyloid and of hyperphosphorylated tau protein -rich neurofibrillary tangles in Alzheimers disease AD accompanied by oxidative stress and sustained inflammation develops approximately 20 years before appearance of symptomatic dementia These years should be regarded as an incubation period of a deadly condition during which early therapeutic intervention may increase the likelihood of obtaining a significant disease modifying effect Early diagnosis at the pre-symptomatic stage has been hindered by the lack of reliable inexpensive and non-invasive biomarkers of disease Recent developments have enabled the measurement of plasma p-tau181 level which has almost 90 sensitivity and specificity for diagnosing AD As these biomarkers identify AD pathology prior to clinical presentation they enable identifying pre-symptomatic patients with potential of early intervention P-tau181 neurofilament light NfL and GFAP biomarkers may also serve as outcome measures corresponding to the severity of active neurodegenerative disease in AD
The investigators propose to select 60 individuals who are at high risk for developing AD dementia for a single-arm prospective intervention study by screening cognitively- and functionally-intact elderly population with non-genetic AD risk factors around 250 individuals 70-79 years old for high plasma p-tau181 level The current lack of any disease modifying drug in AD urged them to test if BCG vaccination can prevent or at least postpone AD The rationale is based on multiple scientific observations and on the dramatic reduction by 30-50 in development of dementia in elderly patients with bladder cancer who were treated with multiple intra-vesicular BCG instillations Accumulating data argue for the critical role of the immune system in the course of AD BCG through its immune-modulation properties Tregs pDCs and IL10 enhancement M1M2 macrophage balance may mitigate the inflammatory process component of AD and therefore may prevent or delay full blown AD
In this single arm prospective study three BCG vaccinations will be provided to the 60 recruited participants over one year At recruitment and at three times during the two years study period they will be tested for plasma p-tau181 level and for plasma Nfl andor GFAP using SIMOA technology The baseline p-tau181 will serve as a reference value for monitoring individual response to the BCG vaccinations during the study as well as the group trend for the total Tau biomarker The investigators will also study the effect of BCG vaccination on the dynamics of the cognitive performance of the selected individuals
The investigators hypothesize that BCG vaccination in individuals with high-risk pre-symptomatic Alzheimers disease will reduce active brain disease as determined by blood biomarkers levels and will mitigate cognitive decline
The investigators propose to select 60 individuals who are at high risk for developing AD dementia for a single-arm prospective intervention study by screening cognitively- and functionally-intact elderly population with non-genetic AD risk factors around 250 individuals 70-79 years old for high plasma p-tau181 level The current lack of any disease modifying drug in AD urged them to test if BCG vaccination can prevent or at least postpone AD The rationale is based on multiple scientific observations and on the dramatic reduction by 30-50 in development of dementia in elderly patients with bladder cancer who were treated with multiple intra-vesicular BCG instillations Accumulating data argue for the critical role of the immune system in the course of AD BCG through its immune-modulation properties Tregs pDCs and IL10 enhancement M1M2 macrophage balance may mitigate the inflammatory process component of AD and therefore may prevent or delay full blown AD
In this single arm prospective study three BCG vaccinations will be provided to the 60 recruited participants over one year At recruitment and at three times during the two years study period they will be tested for plasma p-tau181 level and for plasma Nfl andor GFAP using SIMOA technology The baseline p-tau181 will serve as a reference value for monitoring individual response to the BCG vaccinations during the study as well as the group trend for the total Tau biomarker The investigators will also study the effect of BCG vaccination on the dynamics of the cognitive performance of the selected individuals
The investigators hypothesize that BCG vaccination in individuals with high-risk pre-symptomatic Alzheimers disease will reduce active brain disease as determined by blood biomarkers levels and will mitigate cognitive decline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None